Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003768277

FEI Number

3002807880

Entity Name

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

City/State/Country

BEST Noord-Brabant, NL

Establishment Address

VEENPLUIS 6, BEST Noord-Brabant 5684 PC, NL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Philips Medical Systems International BV (Owner Number: 1217116)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Radiologic Table Zenition 30 VARIOUS MODELS CENTERING LIGHT (OR LASER) Passive Driver 459800607782 MR Elastography System 989603026364 Active Driver 459801514303 FORMAT Collimator Family EchoNavigator R4 Neuro Head Holder Achieva Family T/R HEAD COIL 3T 4598-001-5223x SENSE FLEX L COIL 3T ODU 4522-133-1722x SENSE FLEX M COIL 3T ODU 4522-133-1721x SENSE FLEX S COIL 3T ODU 4522-133-1720x XperCT Rel. 3 Zenition 50 Ingenia Elition R5.7.1 SP4 MR Systems Azurion R2 HF GENERATOR IV 15KW CT XS Generator Velara Certeray IXION III HF GENERATOR Spellman HF generator XS-100 Generator Azurion 7 B20 Azurion 5 M12 Azurion 3 M12 Azurion 3 M15 Azurion 7 M12 Azurion 7 M20 Azurion 5 M20 Azurion 7 B12 SmartCT EchoNavigator R3 MR 7700 Upgrade to MR 7700 SmartPath to Ingenia Elition X BlueSeal SE SmartPath to MR 7700 Ingenia Ambition X Ingenia Elition X Evolution Upgrade 1.5T Upgrades dStream to R12 SmartPath to dStream for 1.5T Evolution Upgrade 3T BlueSeal XE Ingenia Elition S MR 5300 Ingenia Ambition S SmartPath to dStream for 3T LumiGuide 3D Hub LumiGuide Wire LumiGuide Equipment R2 ProxiDiagnost N90 Intera Sensation Family Equipment Rack Intera I/T MR system BuckyDiagnost: TH2, THS DigitalDiagnost C90 LUCY with HeadCoilSet Philips 3T 989603083722 LUCY with HeadCoilSet Philips 1.5T 989603083712 001014 - 2D Quantitative Analysis Table X-Ray Protec 1.5 T eCoil Imaging System for Philips Expression IP5 Information Portal Expression MR200 MRI Patient Monitoring System NiBP Cuff, Single Lumen, Thigh - 989803182681 NiBP Cuff, Single Lumen, Infant #5, Disp - 989803183211 NiBP Cuff, Single Lumen, Infant - 989803182611 NiBP Cuff, Single Lumen, Adult-L - 989803182651 NiBP Cuff, Single Lumen, Neo #1, Disp - 989803183171 NiBP Cuff, Single Lumen, Pediatric - 989803182621 NiBP Cuff, Single Lumen, Lrg Adult-L - 989803182671 NiBP Cuff, Single Lumen, Sample Kit,Disp - 989803182591 NiBP Cuff, Single Lumen, Thigh, Disp - 989803182581 NiBP Cuff, Single Lumen, Lrg Adult - 989803182661 Expression IP5 Software Upgrade - 989803197491 NiBP Cuff, Single Lumen, Neo #4, Disp - 989803183201 NiBP Cuff, Single Lumen,Lrg Adult-L,Disp - 989803182571 NiBP Cuff, Single Lumen, Adult - 989803182641 NiBP Cuff, Single Lumen, Pediatric, Disp - 989803182521 NiBP Cuff, Single Lumen, Neo #3, Disp - 989803183191 NiBP Cuff, Single Lumen, Adult-L, Disp - 989803182551 NiBP Cuff, Single Lumen, Small Adult, Disp - 989803182531 NiBP Cuff, Single Lumen, Adult, Disp - 989803182541 NiBP Cuff, Single Lumen, Neo #2, Disp - 989803183181 Wireless SpO2 Patient Module - 989803183541 NiBP Cuff, Single Lumen, Infant, Disp - 989803182511 NiBP Cuff, Single Lumen, Lrg Adult, Disp - 989803182561 Advanced Apps ECG Cable - 989803176381 NiBP Cuff, Single Lumen, Small Adult - 989803182631 Expression MR Wireless ECG Patient Module - 989803183661 Expression MR200 New MRI Monitor Accessories - 866177 Achieva Ingenia Ingneia CX Ingenia Ambition Intera Ingenia Elition SYN.BODY COIL 1.5T ODU 4598-005-5189x SENSE FLEX S COIL 1.5T ODU 4522-133-1719x T/R Head Coil 1.5T (QHC 1H T/R ACS-NT-L) 4598-002-0529x QUAD HEAD COIL 1.5T 4522-133-1727x SENSE FLEX L COIL 1.5T ODU 4522-133-1715x MRI COILS SYN.BODY COIL 1.5T WITH SLEEVE 4598-000-5187x SENSE SPINE COIL 1.5T ODU 4522-133-1724x SYN.BODY COIL 1.5T ODU WITH SLEEVE 4598-009-6978x SENSE CARDIAC COIL 4522-133-1726x SENSE FLEX M COIL 1.5T ODU 4522-133-1717x SENSE SPINE COIL 1.5T 4522-133-1723x SHNC DRIVERBOX 1.5T 4598-000-5181x SHNC DRIVERBOX 1.5T ODU 4598-000-5182x Achieva 1.5T family Intera 1.5T family SENSE FLEX S COIL 1.5T 4522-133-1718x CIRC.COIL C3 1.5T 4598-000-5196x MICRO 23MM COIL 4598-000-5197x MICRO 47MM COIL 4598-000-5198x ANTERIOR - SYN HEAD/NECK COIL 4598-000-5192x POSTERIOR - SYN HEAD/NECK COIL 4598-000-5193x CIRC.COIL C1 1.5T 4598-000-5184x SENSE CARDIAC COIL 4522-133-1725x SENSE FLEX M COIL 1.5T 4522-133-1716x SENSE FLEX L COIL 1.5T 4522-133-1714x 1.5 T eCoil Imaging System for Philips Pediatric Body-Cardiac Coil 4522-150-41131 dS Ped. TorsoCardiac 8ch 1.5T 4598-000-20671 VesselNavigator CombiDiagnost R90 Medrad Mark V-Plus Injector Ingenia Ambition X Ingenia Ambition S SmartPath to dStream for XR and 3T Upgrades dStream to R5.7 MR 5300 Ingenia Elition S Ingenia Elition X SmartPath to Ingenia Elition X Upgrades Achieva/Intera to R5.7 Evolution Upgrade 1.5T Ingenia Ambition S SmartPath to dStream for 1.5T Ingenia Ambition X Ingenia 3T Evolution Upgrade 3T Achieva, Intera,&Panaroma 1T R2 ALLURACLARITY XPER FD SERIES X-RAY SYSTEM Radiography 7300 C Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems BlueSeal SE BlueSeal XE Examination Light dS Ped. HeadSpine 8ch 1.5T 4598-000-20681 Pediatric Head-Spine Coil 4522-150-41161 Ingenia Elition X R5.4 Ingenia Elition S Dynamic Coronary Roadmap 2 INgenia 1.5T CX and Ingenia 3T CX R5.3 Na-140-Flex Coil 989603031991 C-140-Flex Coil 989603031981 P-140-Flex Coil 989603029722 Knee/Foot Coil 4522-150-40972 MR-CT Roadmap Rel. 1 Allura 3D-RA Rel. 6 3D Roadmap Rel. 1 3D-RA DigitalDiagnost ProGrade SkyPlate MRE Phantom Kit Upgrade to MR 7700 Evolution Upgrade 1.5T SmartPath to MR 7700 SmartPath to Ingenia Elition X BlueSeal XE Ingenia Elition S BlueSeal QE Upgrades dStream to R13 Ingenia Elition X BlueSeal SE MR 7700 Evolution Upgrade 3T MR 5300 Ingenia Elition and MR 7700 MR Systems Achieva 1.5T, 3T, and Intera 1.5T Sense head coil 3T Sense NV Coil 3T Zenition 70 Stentboost R4.2 Zenition 70 Zenition 90 MR 5300 Ingenia 3T CX R5.4 Ingenia 1.5T Ingenia 1.5T CX Ingenia 3T Ingenia 1.5T S MR 5300 and MR 7700 R11 MR Systems Ingenia Elition MR 7700 with Distributed Multi Nuclei Ingenia 3T Ingenia 3TCX Radiological Grid RADIOGRAPHIC GRID BuckyDiagnost ProxiDiagnost N90 / Precision CRF Ingenia Elition S Ingenia Elition X Interventional Workspot Pediatric Body-Cardiac Coil 4522-133-18721 dS Ped. TorsoCardiac 8ch 3T 4598-000-20651 Quick Connect SpO2 Grip, Adult, 20/box - 989803166551 Quick Connect SpO2 Grip, Ped, 20/box - 989803166561 Quick Connect SpO2 Clip, Adult - 989803166531 Quick Connect SpO2 Probe, MRI - 989803161991 Quick Connect SpO2 Clip, Pediatric - 989803166541 CAB,4 LD,NEO.MRI ECG - 9222 SpO2 SENSOR GRIP ADULT/NEONATAL 2 PACK - 989803162501 GRIP SENSOR STARTER KIT - 989803162491 SpO2 SENSOR GRIP INFANT/PEDIATRIC 2 PACK - 989803162511 PNEUMOGRAPH, CHEST, NON-MAGNETIC, 3160 - 94023 Quick Connect SpO2 Grip, Infant, 20/box - 989803166571 KIT,SAMPLE,AGENTS,3160 - 94018 Anesthetic Oxygen (O2) Sensor - 989803162051 CUFFF,CHILD,MRI,COLDER CONN - 989803169441 CAB,4 LD,MRI ECG - 9224 Quick Connect SpO2 Starter Kit - 989803167111 Quick Connect SpO2 Grip, Neo, 20/box - 989803166581 Wireless SP02 Module (Gen 2) - 989803163111 Wireless ECG Module - 989803163121 ADVANCED FILTER ECG CABLE - 989803170121 Expression MR Cuff, Disp, NEO, MRI, Size #5 - 989803170421 Expression MR Cuff, Disp, NEO, MRI Size #3 - 989803170401 CAB,4 LD,CV MRI ECG - 9223 MRI Patient Monitoring System, Mode EmboGuide R1 EP Navigator R5 Azurion 7 M20 Azurion 3 M12 Azurion 7 B20 Azurion 5 M20 Azurion 5 M12 Azurion 3 M15 Azurion 7 M12 Azurion 7 B12 Azurion 7 B12 Azurion 3 M15 Azurion 5 M12 Azurion 7 M12 Azurion 3 M12 Azurion 7 B20 Azurion 5 M20 Azurion 7 M20 DigitalDiagnost EchoNavigator Release 1 BuckyDiagnost CT TrueView - 001010 XperGuide DU, DR CTR22xx Series H.T Converter Tank BV300 Spellman Monoblock XS-100 X-ray tube assembly X-Ray Tube, Brightview XCT SRO (Super Rotalix) CTR17xx Series CTR21xx Series CTxxxx Series Monoblock IXION V RO (Rotalix) SRM (Super Rotalix Metal) MRM (Maximus Rotalix Metal) IXION MONOBLOCK DRxxx Series DAxxx Series vMRC Performance CT XS Tube MRC (Maximus Rotalix Ceramic) DUxxx Series CombiDiagnost R90 Flexibility with Headcoilset Philips1.5T 989603051092 Flexibility with Headcoilset Philips3T 989603051102 Ingenia 1.5T S - 781-347 Ingenia 1.5T - 781-341 EchoNavigator R5

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	2006-02-21
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2024-02-20
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2024-02-20
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2024-02-20
IWE	Monitor, Patient Position, Light-Beam	Radiology	Class 1	892.5780	2001-06-12
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-01-09
IZX	Collimator, Manual, Radiographic	Radiology	Class 2	892.1610	2006-02-21
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2006-02-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-07-12
IWY	Holder, Head, Radiographic	Radiology	Class 1	892.1920	1978-03-30
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2009-05-15
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-06-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-06-11
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2019-03-27
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2019-03-27
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2019-03-27
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-08-10
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2023-08-10
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-08-08
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-08-08
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2006-02-21
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2020-05-13
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2020-05-13
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-02-12
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-02-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-02-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-04-14
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-06-16
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-06-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2024-03-19
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2024-03-19
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-02-13
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-02-13
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2009-05-15
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2021-01-11
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2009-05-15
IZZ	Table, Radiographic, Non-Tilting, Powered	Radiology	Class 2	892.1980	2006-02-21
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2020-10-05
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-10-05
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2020-10-05
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2023-01-09
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2023-01-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-08-02
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2016-08-02
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2021-01-11
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2024-10-31
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2013-08-05
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2020-04-14
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2020-04-14
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2009-05-15
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2024-10-31
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2023-01-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-10-19
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2015-10-19
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2017-02-10
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2017-02-10
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2017-02-10
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2006-02-21
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2018-08-14
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2018-08-14
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-08-20
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-08-20
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2009-05-15
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-06-11
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2024-06-20
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2024-06-20
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2023-04-14
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-04-14
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2021-01-11
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2023-01-09
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2018-03-07
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2018-03-07
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-11-02
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2017-11-02
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2017-01-10
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2017-01-10
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2023-01-09
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2023-01-09
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-06-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-06-11
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-06-11
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2014-07-29
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-07-29
IXF	Test-Pattern, Radiographic	Radiology	Class 1	892.1940	1978-03-30
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2026-03-19
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2026-03-19
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2023-05-01
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-05-01
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2019-06-12
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2019-06-12
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2019-03-27
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2019-03-27
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2019-03-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-06-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-06-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-10-15
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2021-10-15
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-10-15
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2024-05-24
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2024-05-24
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2024-05-24
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2021-11-22
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2021-11-22
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2018-04-11
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2018-04-11
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2023-01-03
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-01-03
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2022-03-04
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2022-03-04
IXJ	Grid, Radiographic	Radiology	Class 1	892.1910	2001-12-03
IXQ	Table, Radiographic, Stationary Top	Radiology	Class 2	892.1980	2006-02-21
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2024-01-17
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2024-01-17
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2018-03-22
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2018-03-22
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-11-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-11-15
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2023-01-09
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2010-01-27
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-03-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-03-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2015-03-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-01-16
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2015-01-16
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2026-02-05
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2026-02-05
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-11-19
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-11-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-05-25
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-05-25
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2021-05-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-03-20
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	Class 1	892.1770	2006-02-21
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2016-08-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-08-16
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-06-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-06-11
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2006-02-21
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2023-11-03
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2023-11-03
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2023-01-09
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2023-01-09
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2016-03-31
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2016-03-31
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-03-19
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-03-19

Official Correspondent

No official correspondent registered.

US Agent Details

Maria Heiling Business: Philips Email: maria.heiling@philips.com Phone: (858) 2487651

Related Public Records

Same Entity

Philips Medical Systems International BV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

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510(k) Number	Applicant	Device Name	Decision Date
K163715	Philips Medical Systems Nederland B.V.	Allura Xper R9	2017-01-26
K863853	Superior Medical Products	EAZY COVERS	1987-03-06
K953974	Medivision Medical Imaging, Ltd.	CAMVISION 1000	1996-09-09
K024012	Ge Oec Medical Systems	OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM	2003-03-20
K970608	Guidant Cardiac and Vascular Surgery	EVT MARKER BOARD	1997-04-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0002-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0003-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0004-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0005-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0006-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0007-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0008-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0009-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0010-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0011-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0012-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0013-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0014-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0015-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Similar Registrations

Registration Number	Establishment Name	Location
3010949642	GE HEALTHCARE (TIANJIN) COMPANY LIMITED	Tianjin, CN
3011491794	ECOTRON Co., Ltd.	Seoul, KR
3013836619	Baxter Medical Systems (Suzhou) Co. Ltd	Taicang City Jiangsu, CN
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA
3014680784	Domico Med-Device, LLC	Fenton, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003768277. Last updated year: 2026. Please use registration number 3003768277 when referencing this establishment in official correspondence.